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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204421
Company: AUROBINDO PHARMA LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/20/2015 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204421Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204421Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-6 REMS - PROPOSAL - D-N-A

Label is not available on this site.
09/11/2018 SUPPL-5 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/29/2017 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/21/2017 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/20/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204421Orig1s000lbl.pdf
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